BLOOD DONOR CONSENT FORM
Title of Study:
Blood collection for the molecular analysis of Mycobacterium
tuberculosis signaling
Principal Investigator:
Yossef Av-Gay, PhD
Professor – Division of Infectious Diseases,
University of British Columbia
604-875-4329
Sponsors:
Canadian Institutes of Health Research
Immunity and Infection Research Centre
VGH & UBC Hospital Foundation
Research Nurse:
Connie Feschuk RN, MSHS
Clinical Research Unit Manager
604-875-5886
Research Coordinator:
Jeffrey Helm
604-875-4111 x68576
Emergency Number:
604-875-5000
*Ask for Infectious Disease Clinician on Service*
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You are being invited to take part in this research study because you are interested in
providing a sample of your blood for research on infection and immunological processes
(body’s protection against disease).
Your participation is entirely voluntary, so it is up to you to decide whether or not to take
part in this study. Before you decide, it is important for you to understand why the
research is being done and what it will involve. If you wish to participate, you will be
asked to sign this form. You do not have to provide any reason should you decide not to
participate. Should you refuse to participate or withdraw, it would not in any way
jeopardize your future medical care at this institution. You can withdraw from the study
at any time without providing any reasons for your decision. You can declare your
intention to withdraw by informing a research nurse involved in the study, or calling one
of the contact numbers provided at the bottom of this document. If you decide to
withdraw after already donating blood and before the blood is processed, your blood
donation will be destroyed. You will not be able to withdraw your participation after the
blood is processed because at that point components of the blood cells have already
been incorporated into experiments involving tuberculosis.
This study is being conducted by Dr. Yossef Av-Gay a member of the Infection and
Immunity Research Centre at the Vancouver Coastal Health Research Institute and the
University of British Columbia. The study is sponsored by the Canadian Institutes of
Health Research.
The purpose of this study is to develop new ways to improve treatments for a variety of
infectious diseases by studying the interactions between white blood cells and
pathogens (organisms that cause diseases or illness). The overall goal is to identify
common pathways in the body’s immune response to infections in order to develop new
treatments to combat infectious diseases.
Specifically the Molecular analysis of Mycobacterium tuberculosis signaling research
project needs blood from healthy donors with the blood group AB+, who have not been
exposed to tuberculosis, or vaccinated with the Bacillus Calmette–Guérin vaccine
(BCG), in order to support research studying the pathogenesis of tuberculosis, and
mechanisms the pathogen uses to infect and reside in mononuclear phagocytes in the
blood. The goal of this research is to develop novel diagnostics and therapeutics to treat
tuberculosis and other diseases that compromise the normal functions of blood
monocytes.
This study requires blood from healthy subjects, and could not be performed with any
other type of material.
Approximately 4 subject per year will be needed, over a period of 3 years, to complete
this research.
You are eligible to participate in this study because you are between 19 and 60 years of
age, are in good health and weigh at least 50 kg (110 lbs). In addition, you are AB
positive and are tuberculin skin test negative, or have no history of exposure to TB and
are a Canadian born Caucasian, or Canadian born with no travel history outside North
America.
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You cannot participate in this study if have donated blood within the last 56 days; have
been diagnosed with HIV, hepatitis, or other infectious diseases; have engaged in high
risk activities that facilitate infectious disease transmission (including intravenous drug
use); have had heart problems or heart surgery; have diabetes and are on insulin; or
you are pregnant.
The Procedures, if you agree to take part in this study, will include the following:

A brief physical exam to measure your weight, blood pressure, and temperature

A questionnaire about your health and any high-risk activities

Blood withdrawal from a vein in your arm through a sterile needle by a trained
member of the Vancouver Costal Health Research Institute Clinical Research
Unit. You may experience momentary discomfort associated with insertion of the
needle, and a small bruise occasionally occurs at the puncture site.

50ml of blood will be collected (~1/4 cup, 10x less than the amount of a standard
donation at Canadian Blood Services).

Although the amount of blood to be removed will not exceed 10% of your total
blood volume, some people have a reaction to the discomfort from the needle.
About 1% of people will experience mild pain and swelling at the needle site,
sweating, dizziness, gastrointestinal disorders, decreased blood pressure, slow
pulse. More severe adverse reactions of nausea and fainting occur only 0.2% of
the time. If you have any of these symptoms during the blood withdrawal, the
procedure will be stopped. These symptoms usually subside after a few minutes
of rest.
The visit will take approximately 50 minutes, which includes time for consenting to the
study, the physical examination, questionnaire, blood collection, and time for small
snack. You will be observed by the Clinical Research Unit staff during your donation and
up to the time you leave the unit.
The blood that was removed will be regenerated by the bone marrow within 4 weeks,
and there are no long-term side effects associated with the procedure.
The cells from your blood may be used immediately, or frozen for use at a later date.
However, regardless of whether they are used immediately or stored in liquid nitrogen,
your cells will be used strictly for research as describe above. No other investigators will
have access to the material, and it will not be stored as part of the inventory of a blood
bank. Once your donation has been used for its intended purpose, any remnants will be
destroyed.
Confidentiality
Your confidentiality will be respected. No information that discloses your identity will be
released or published without your specific consent to the disclosure. However, research
records and medical records identifying you may be inspected, in the presence of the
Investigator or his or her designate, by representatives of the UBC Research Ethics
Board for the purpose of monitoring the research.
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You will be assigned a unique study number as a subject in this study. Only this number
will be used on any research-related information collected about you during the course
of this study, so that your identity [i.e. your name or any other information that could
identify you] as a subject in this study will be kept confidential. Information that contains
your identity will remain only with the Principal Investigator and/or designate. The list
that matches your name to the unique study number that is used on your researchrelated information will not be removed or released without your consent unless required
by law. In rare instances it will not be possible to ensure confidentiality because of
mandatory reporting laws. This legal obligation includes a number of circumstances,
such as suspected child abuse and infectious disease, expression of suicidal ideas,
where research documents are ordered to be produced by a court of law and where
researchers are legally obliged to report to the appropriate authorities.
The investigators and/or their partners/immediate family members will not receive any
personal benefits connected to this research study.
You should understand that Canadian legislation prohibits the sale of human tissues,
including blood. You will however receive $20 to compensate your for your time and
travel expenses.
If you have any questions or desire further information about this study before, during or
after participation, you can contact Connie Feschuk, the Manager of the Clinical
Research Unit at 604.875.5886. You may also contact Jeffrey Helm, Research
Coordinator for this project, at 604-875-4111, extension 68576, should you wish to be
informed of the progress in this project, and/or of how the data collected from the blood
you donate has contributed to improving the success of treating infectious diseases.
If you have any concerns or complaints about your rights as a research subject and/or
your experiences while participating in this study, contact the Research Subject
Information Line in the University of British Columbia Office of Research Services by email at RSIL@ors.ubc.ca or by phone at 604-822-8598 (Toll free: 1-877-822-8598).
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Blood collection for The Immunity and Infection Research Centre;
Molecular analysis of Mycobacterium tuberculosis signaling
My signature on this consent form means:

I have read and understood the subject information and consent form.

I have had sufficient time to consider the information provided and to ask for
advice if necessary.

I have had the opportunity to ask questions and have had satisfactory responses
to my questions.

I understand that all of the information collected will be kept confidential and that
the results will only be used for scientific objectives.

I understand that my participation in this study is voluntary and that I am
completely free to refuse to participate or to withdraw from this study at any time
without jeopardizing my future medical care at this institution.

I understand that I am not waiving any of my legal rights as a result of signing this
consent form.

I have read this form and I freely consent to participate in this study.

I have been told that I will receive a dated and signed copy of this form.
Printed name of subject
Printed name of person
obtaining consent
Signature
Signature
Date
Date
I would like to be contacted for future donations ________________________________
subject signature
I do not want to be contacted for further donations ________________________________
subject signature
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